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Formulation and Evaluation of Delayed Release Capsule of Dimethyl Fumarate with Novel Technology
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| Author:
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ANJALI KUMARI, RAJESH KUMAR, BALWAN SINGH
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| Abstract:
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Dimethyl fumarate is an anti-inflammatory agent which is indicated for the treatment of multiple sclerosiswith
relapsing formsand for psoriasis. The aim of this study was to prepare and evaluate delayed release capsule of
Dimethyl fumarate with raft technology to reduce the flushing, a common side effect. The core mini tablets
were prepared by direct compression method &enteric coating was done by perforated coating pan. Preformulation
studies like angle of repose, bulk density, tapped density, Carr's index,Hausner's ratio & angle of
repose were carried out. Evaluation of Post compression parameters such as Hardness, thickness, friability,
weight variation disintegration and dissolution. The F05 batch shows the highest drug release at 45 min in pH
6.8 phosphate buffer was 97.13 % which are the satisfactorily results. After that encapsulation done which
contains enteric coated mini tablets along with raft blend sothe formulation was formed a complex gel like
structure in which mini tablets are trapped and dropped one by one with specified time interval. The F05 was
the optimized batch among all six batches & blend 01 among all five blends are selected as per result. The raft
technology was successfully applied on delayed release capsule increaseslag time thus decreasing flushing.
Stability studies indicated that the developed dosage form was stable and retained their pharmaceutical
properties at room temperature and accelerated conditions.
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| Keyword:
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Dimethyl fumarate, Raft technology, Delayed release capsules, Relapsing Remitting multiple sclerosis.
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2019.11.04.073
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| Download:
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